April 17, 2024

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FDA approved Myfembree for menorrhagia related to uterine fibroids



US FDA approved Myfembree, a Myovant/Pfizer product, for the treatment of menorrhagia related to uterine fibroids in premenopausal women!

FDA approved Myfembree for menorrhagia related to uterine fibroids.  Pfizer (Pfizer) and Myovant Sciences recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree (relugolix 40mg, estradiol 1.0mg, norethinol acetate). Ketone 0.5mg), the drug is a compound tablet of relugolix, which is the first once-daily drug for the treatment of uterine fibroids-related menorrhagia (HMB) in premenopausal women, and the treatment duration can be as long as 24 months.

In December 2020, Pfizer and Myovant reached a $4.2 billion agreement to jointly develop relugolix, an oral gonadotropin releasing hormone (GnRH) receptor antagonist. According to the terms of the cooperation, Myovant and Pfizer will jointly commercialize Myfembree in the United States, and the product is expected to be launched in June 2021.

Uterine fibroids are a chronic debilitating disease. The two most common symptoms are menorrhagia (HMB) and pain. In the United States, uterine fibroids affect millions of women, and there are more than 250,000 hysterectomy procedures each year. The approval of Myfembree will bring a convenient, non-invasive treatment for women with uterine fibroids, taking one tablet daily, and providing clinically meaningful relief for menorrhagia.

It is worth mentioning that AbbVie’s compound product Oriahnn (elagolix, estradiol, norethindrone acetate capsules) is the first non-surgical, oral option for the treatment of uterine fibroids-related menorrhagia (HMB) in premenopausal women. The drug was approved by the US FDA in May 2020. In terms of medication, Oriahnn is taken orally twice a day. Among the active ingredients of the drug, elagolix is ​​also an oral GnRH receptor antagonist.

In July 2018, elagolix (trade name: Orilissa) was approved by the US FDA for the treatment of moderate to severe pain associated with endometriosis (EMs). This approval makes Orilissa the first oral GnRH receptor antagonist approved for the treatment of moderate to severe pain related to EMs, and it is also the first oral drug approved by the FDA for the treatment of moderate to severe pain related to EMs in the past 10 years.

FDA approved Myfembree for menorrhagia related to uterine fibroids

 

The FDA approved Myfembree based on the efficacy and safety data of 2 phase 3 studies (LIBERTY 1, LIBERTY 2). Related results were published in the international medical journal “New England Journal of Medicine” (NEJM) in February this year, with the title of the article: Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. As mentioned earlier, both studies reached the primary endpoint of menstrual loss relief, and at the same time reached 6 of the 7 key secondary endpoints. Myfembree also maintained bone density comparable to placebo, which is a good resistance within 24 weeks. Part of the subject of security.

The specific data are as follows: In the two studies, 72.1% and 71.2% of the women in the Myfembree group reached the remission standard at the 24th week of treatment, while the placebo group was 16.8% and 14.7% (both p<0.0001). Treatment remission is defined as: measured by the alkaline hemoglobin method, during the last 35 days of treatment, menstrual blood loss decreased by 80 ml from the baseline and decreased by ≥50% from the baseline. In patients treated with Myfembree, menstrual blood loss decreased by 82.0% and 84.3% from baseline, respectively (p<0.0001 compared with placebo). Among patients treated with Myfembree, adverse reactions that occurred at a rate of ≥3% and higher than placebo included: flushing, abnormal uterine bleeding, hair loss, and decreased libido. In these two studies, no pregnancy was reported in the Myfembree treatment group.

 

Relugolix is ​​an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, which can reduce the production of ovarian estradiol by blocking GnRH receptors in the pituitary gland. This hormone is known to stimulate uterine fibroids and uterus The growth of endometriosis. In addition, relugolix can also inhibit the production of testosterone in the testicles, which can stimulate the growth of prostate cancer cells.

Currently, relugolix is ​​being developed for 3 therapeutic indications: (1) treatment of female uterine fibroids and endometriosis; (2) treatment of male prostate cancer.

relugolix was developed by Takeda, and Myovant Sciences (a company formed by Roivant and Takeda) obtained the exclusive global license in June 2016 except Japan and other Asian countries. In Japan, relugolix was approved in January 2019 and marketed under the brand name Relumina to improve the following symptoms caused by uterine fibroids: menorrhagia, lower abdominal pain, low back pain and anemia.

 

 

Myfembree (relugolix 40mg, estradiol 1.0mg, norethindrone acetate 0.5mg) marks Myovant’s second product approved by the US FDA in less than 6 months in the development of relugolix. On December 18, 2020, Orgovyx (relugolix, 120mg tablets) was approved by the FDA for the treatment of adult patients with advanced prostate cancer.

It is worth mentioning that Orgovyx is the first and only oral GnRH receptor antagonist approved by the US FDA for the treatment of advanced prostate cancer. The drug was approved through the priority review process. In the phase 3 HERO study, the remission rate of relugolix treatment was as high as 96.7%, which was significantly better than leuprolide acetate (88.8%), while reducing the risk of major cardiovascular adverse events (MACE) by 54%.

Myovant plans to submit a new indication application for Myfembree to the US FDA in the first half of 2021 for the treatment of moderate to severe pain related to female endometriosis. In addition, based on the 100% inhibition rate of relugolix compound tablets on female ovulation in the phase 1 study, Myovant and Pfizer launched a phase 3 clinical trial in April this year to evaluate the contraceptive effect of relugolix compound tablets in high-risk female populations.

(source:internet, reference only)


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